Olympus WA50023SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761066709), received between May 24, 2024 and Jun 6, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image4
- Break2
- Dent in Material2
- No Display/Image2
- Crack1
- Detachment of Device or Device Component1
- Environmental Particulates1
- Image Orientation Incorrect1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2026Poor Quality Image
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING DEVICE EVALUATION, THE REPAIR CENTER TECHNICIAN IDENTIFIED THE DEVICE HAD TWISTED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25419028 ↗MalfunctionApr 22, 2026Poor Quality Image
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A CAMERA LIGHT IS VERY DARK . THE ISSUE WAS IDENTIFIED DURING REPROCESSING, AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955929 ↗MalfunctionApr 8, 2026Break; Poor Quality Image; Dent in Material; Detachment of Device or Device Component; Environmental Particulates; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD FIBER BREAKAGE, DENT ON DISTAL EDGE, SCRATCHES ON DISTAL EDGE, REFLECTIONS ON IMAGE, MISSING LIGHT GUIDE ADAPTER, AND EXCESSIVE DIRT OF OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821186 ↗MalfunctionJul 12, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED AN IMAGE ISSUE (STREAKS) DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22488573 ↗MalfunctionAug 14, 2024Break; Crack; Image Orientation Incorrect; Dent in Material; Material Integrity Problem; Material Twisted/Bent; Break; Crack; Image Orientation Incorrect; Dent in Material; Material Integrity Problem; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTAL FIBER BREAKAGE, DENTS ON DISTAL EDGE, DEBRIS UNDER COVER GLASS, CRACKS ON SIDE OF VIDEO CONNECTOR AND IMAGE OUT OF FIELD VIEW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19981869 ↗MalfunctionJun 14, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT, DURING PREPARATION FOR USE, THE RIGID VIDEOSCOPE DISPLAYED NO PICTURE WHEN PLUGGED IN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537339 ↗MalfunctionMay 24, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS NO IMAGE ON THE VIDEO SCOPE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE AND THERE WERE NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19389323 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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